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Идёт набор NCT06523166

Direct Comparison of Cardiac CT With TEE to Evaluate Watchman FLX LAA Occluder Device Characteristics

Без фазы С лечением Device Related Thrombosis Peri-device Leak

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Transesophageal echocardiography (TEE), Cardiac CTA.
Кому может быть актуально
Состояния в реестре: Device Related Thrombosis, Peri-device Leak. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

Direct Comparison of Cardiac CT With TEE to Evaluate Watchman FLX LAA Occluder Device Characteristics: A Multicenter Study

Обзор

The current standard of care for patients who underwent left atrial appendage closure (LAAC) is to have follow-up transesophageal echocardiogram (TEE) for device surveillance. TEE is an ultrasound of the heart done by placing a probe in the esophagus under conscious sedation. It does not use contrast but can be cumbersome to patients as it involves placing a probe in the esophagus. Cardiac computerized tomography angiography (cardiac CTA) is a non-invasive imaging modality that involves the use of certain types of x-rays, contrast (dye) and special computers to generate accurate images of the heart. Participants in this study will undergo both TEE and CTA on the same day 90 days after their LAAC procedure. Participants will be in this research study for a period of 1 year, starting from the day of their scheduled LAAC procedure. Participants will undergo a TEE at 90 days after their procedure which is the standard of care imaging study after LAAC. As part of this study, participants will also undergo a cardiac CTA at 90 days as well. Participants will have a routine follow-up visit following device placement as per standard of care as well as a brief phone "check in" at 1 year.

Вмешательства

  • Процедура Transesophageal echocardiography (TEE)
    TEE will be performed using a 3D probe. TEE images will be acquired at the standard 0, 45, 90, and 135 degree views along with a 3D acquisition encompassing the entire LAA, device, left pulmonary vein and lateral mitral annular landmarks.
  • Процедура Cardiac CTA
    Cardiac CTA will be performed with ECG gating using systems with ≥ 64 detector rows and with temporal resolution that is at least 175 msec (rotation speed ≤ 350 msec for single source systems). Cardiac CTA images will be acquired for the entire cardiac cycle without ECG phase specific pulsing and with contrast appropriately timed for peak left atrial/arterial phase contrast enhancement. In addition, a targeted end systolic only delayed phase image set (45 seconds after the arterial phase scan an

Первичные конечные точки

  • LAA patency percentage associated with peri device leak (PDL) as measured by CT scan/TEE [Срок оценки: 3 months post procedure]
  • LAA patency percentage associated with intra device leak (IDL) as measured by CT scan/TEE. [Срок оценки: 3 months post procedure]
  • LAA patency percentage associated with a combination of both PDL and IDL as measured by CT scan/TEE. [Срок оценки: 3 months post procedure]
  • Number of detected device-related thrombus (DRT) as measured by CT scan/TEE. [Срок оценки: 3 months]
Вторичные конечные точки (5)
  • Average size of device measured in millimeters (mm) [Срок оценки: 3 months]
  • Percent of compression as measured by CT scan/TEE [Срок оценки: 3 months]
  • Average depth of implant measured in millimeters (mm) [Срок оценки: 3 months]
  • Average hypo-attenuated thickening (HAT) measured in millimeters (mm) [Срок оценки: 3 months]
  • Number of adverse events as measured by medical record [Срок оценки: Up to 7 days]

Критерии участия

Критерии включения

  • Subjects >18 years old planned to undergo LAAC
  • eGFR ≥ 30 mL/min per 1.73 m2

Критерии исключения

  • Subjects below the age of 18
  • non-English speaking subjects
  • eGFR < 30 mL/min per 1.73 m2
  • Subjects with history of contrast allergy
  • Pregnant women

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Диагностика

Центры проведения

США · 5 центров
  • Cedars Sinai — Los Angeles
  • St. Francis Hospital and Catholic Health — Roslyn
  • Sanger Heart & Vascular Institute- Atrium Health — Charlotte
  • University Hospitals Cleveland Medical Center — Cleveland
  • Ohio State University Medical Center — Columbus

Идентификаторы

NCT: NCT06523166 · STUDY20231491

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗